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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033724
Receipt No. R000038458
Scientific Title Prospective observational study to assess Achilles tendon thickness in patients with acute coronary syndromes
Date of disclosure of the study information 2018/08/13
Last modified on 2020/02/12

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Basic information
Public title Prospective observational study to assess Achilles tendon thickness in patients with acute coronary syndromes
Acronym Prospective observational study to assess Achilles tendon thickness in patients with acute coronary syndromes
Scientific Title Prospective observational study to assess Achilles tendon thickness in patients with acute coronary syndromes
Scientific Title:Acronym Prospective observational study to assess Achilles tendon thickness in patients with acute coronary syndromes
Region
Japan

Condition
Condition Acute coronary syndromes
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The goal of this study is to evaluate the efficacy of measurements of Achilles tendon thickness in patients with acute coronary syndromes using sonography and magnetic resonance imaging and to assess the longitudinal change of Achilles tendon thickness and its quality.
Furthermore, this study is aimed to assess the association between Achilles tendon thickness and coronary and carotid artery plaque.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The thickness of Achilles tendon measured by sonography and MRI at baseline and at 8 months follow up
Key secondary outcomes -Death and cardiovascular events at 8 monthsfollow up(death, cardiovascular events[myocardial infarction, revascularization, non-fatal MI, heart failure])
-Prevalence of familial hypercholesterolemia in patients with acute coronary syndromes
-Association between thickness of Achilles tendon and coronary and carotid artery plaque
-Fat distribution of Achilles tendon measured by MRI and its longitudinal change

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent percutaneous coronary intervention for acute coronary syndromes
Key exclusion criteria Patients who are under 20 years old
Patients who can not undergo percutaneous coronary intervention
Patients who physicians determined were inappropriate
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kazuyuki
Middle name
Last name Yahagi
Organization Mitsui Memorial Hospital
Division name Division of cardiology
Zip code 1018643
Address Kandaizumicho 1, Chiyoda-ku, Tokyo, Japan
TEL 03-3862-9111
Email yyahakazu@gmail.com

Public contact
Name of contact person
1st name Tetsu
Middle name
Last name Tanaka
Organization Mitsui Memorial Hospital
Division name Division of cardiology
Zip code 1018643
Address Kandaizumicho 1, Chiyoda-ku, Tokyo, Japan
TEL 03-3862-9111
Homepage URL
Email ttanaka@mitsuihosp.or.jp

Sponsor
Institute Mitsui Memorial Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Mitsui Memorial Hospital
Address Kandaizumicho 1, Chiyoda-ku, Tokyo
Tel 0338629111
Email ttanaka@mitsuihosp.or.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 13 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 07 Month 05 Day
Date of IRB
2018 Year 07 Month 05 Day
Anticipated trial start date
2018 Year 08 Month 15 Day
Last follow-up date
2023 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 08 Month 12 Day
Last modified on
2020 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038458

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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